Regaine Extra Strength 5% solution

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Minoxidil

Disponible depuis:

Pfizer Consumer Healthcare Ltd

Code ATC:

D11AX01

DCI (Dénomination commune internationale):

Minoxidil

Dosage:

50mg/1ml

forme pharmaceutique:

Cutaneous solution

Mode d'administration:

Cutaneous

classe:

No Controlled Drug Status

Type d'ordonnance:

Invalid to prescribe in NHS primary care

Descriptif du produit:

BNF: 13090000

Notice patient

Warning
Flammable Liquid
PATIENT INFORMATION LEAFLET
®
Cutaneous solution
Scalp
Solution
5% w/v
Minoxidil
EXXXXXX
FPO
69.85mm
IFC
139.7mm
130.2mm
69.85mm
IBC
69.85mm
Front Cover Varnish
130.2mm
69.85mm
3.15mm
BODY COPY SIZE 7pt
Regaine Men's Solution 5% 1x60, 3x60 (Flammable warning + Triple pack
P to GSL switch)
25.09.18
PC-025169
401074100_V3R2
UK
130.2MM X 69.85MM
Leaflet
ASM
TBC
Sparndruck
EX50208_205434
Offset
TBC
WHITE PAPER
TBC
CTE
BLACK
PMS
300 C
PMS
185 C
PMS
8382 C
VARNISH
DIN-Medium
DIN-Regular
HelveticaNeue-Bold
HelveticaNeue-MediumItalic
HelveticaNeueCE-Medium
HelveticaNeueLTStd-CnO
HelveticaNeueLTStd-Roman
OCRB
ZapfDingbatsITC
1
scalp solution 5% w/v minoxidil
cutaneous solution to be applied to the scalp
■ This medicine is used to treat hereditary hair loss in
men aged 18 – 65 years.
■ This product is for men only and should NOT be
used by women.
■ Do not apply to other areas of the body other than
the scalp. If accidentally applied rinse thoroughly
with plenty of water. _See section 2 _
■ THERE ARE 2 DIFFERENT WAYS YOU CAN APPLY THIS
PRODUCT, CHOOSE THE BEST OPTION FOR YOU AND
FOLLOW THE INSTRUCTIONS ON HOW TO USE THIS
PRODUCT CAREFULLY. _See section 3 _
■ THIS MEDICINE IS FOR EXTERNAL USE ONLY AND SHOULD
ONLY BE APPLIED TO YOUR SCALP. _See section 3 _
■ THIS PRODUCT IS FLAMMABLE AND SHOULD BE USED AND
DISPOSED OF CAREFULLY. See Special Warnings Relating
to Regaine for Men Extra Strength Scalp Solution
5% w/v. _See section 2 _
IN THIS LEAFLET
1
WHAT THE MEDICINE IS AND WHAT IT IS USED FOR page 2
2
WHAT YOU NEED TO KNOW BEFORE YOU USE THIS
MEDICINE page 3
3
HOW TO USE THIS MEDICINE page 5
4
POSSIBLE SIDE-EFFECTS page 8
5
HOW TO STORE THIS MEDICINE page 10
6
CONTENTS OF THE PACK AND OTHER INFORMATION page 10
NOW READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU. Keep the leaflet: you may need to
read it again.
1 WHAT THE MEDICINE IS AND
WHAT IT IS USED FOR
Regaine for Men Extra Strength Scalp Solution 5% w/v
is a

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Regaine for Men Extra Strength Scalp Solution 5% w/v Cutaneous
Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Minoxidil 50 mg/ml (5%w/v).
Contains propylene glycol. For full list of excipients, see section
6.1
3
PHARMACEUTICAL FORM
Cutaneous Solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Regaine for Men Extra Strength Scalp Solution 5% w/v Cutaneous
Solution
is indicated for the treatment of alopecia androgenetica in men.
Onset and degree of hair regrowth may be variable among users.
Although
trends in the data suggest that those users who are younger, who have
been
balding for a shorter period of time or who have a smaller area of
baldness on
the vertex are more likely to respond to Regaine for Men Extra
Strength Scalp
Solution
5%
w/v
Cutaneous
Solution,
individual
responses
cannot
be
predicted.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Men aged 18-65:
Hair and scalp should be thoroughly dry prior to topical application
of Regaine for
Men Extra Strength Scalp Solution 5% w/v Cutaneous Solution. A dose of
1 ml
Regaine for Men Extra Strength Scalp Solution 5% w/v Cutaneous
Solution
should be applied to the total affected areas of the scalp twice
daily. The total dosage
should not exceed 2 ml. If fingertips are used to facilitate drug
application, hands
should be washed afterwards.
It may take twice daily applications for 2 months or more before
evidence of hair
growth can be expected.
If hair regrowth occurs, twice daily applications of Regaine for Men
Extra Strength
Scalp Solution 5% w/v Cutaneous Solution are necessary for continued
hair growth.
Anecdotal reports indicate that regrown hair may disappear three to
four months after
stopping Regaine for Men Extra Strength Scalp Solution 5% w/v
Cutaneous Solution
application and the balding process will continue.
Users should discontinue treatment if there is no improvement after
one year.
SPECIAL POPULATIONS
There are no specific recommendations for use in patients with renal
or he